Alignment of ultrasound transducer arrays and multiple aperture probe assembly

ABSTRACT

The effective aperture of an ultrasound imaging probe can be increased by including more than one transducer array and using the transducer elements of all of the arrays to render an image can greatly improve the lateral resolution of the generated image. In order to render an image, the relative positions of all of the elements must be known precisely. Systems and methods for accurately calibrating and adjusting a multi-aperture ultrasound system are disclosed. The relative positions of the transducer elements can be computed and aligned prior to and during probe assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/210,015, filed Mar. 13, 2014, now U.S. Pat. No. 9,510,806, whichapplication claims the benefit of U.S. Provisional Patent ApplicationNo. 61/780,366, filed Mar. 13, 2013, titled “Alignment of UltrasoundTransducer Arrays and Multiple Aperture Probe Assembly”, the contents ofeach application incorporated by reference herein.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD

The present invention relates generally to imaging techniques, and moreparticularly to ultrasound imaging, and still more particularly tosystems and methods for calibration and quality assurance measurement ofultrasound probes, particularly probes having multiple apertures.

BACKGROUND

In conventional (scanline-based) ultrasonic imaging, a focused beam ofultrasound energy (a scanline) is transmitted into body tissues to beexamined and echoes returning along the same scanline are detected andplotted. A complete image may be formed by combining multiple scanlines.While ultrasound has been used extensively for diagnostic purposes,conventional scanline-based ultrasound has been greatly limited by depthof scanning, speckle noise, poor lateral resolution, obscured tissuesand other problems.

Significant improvements have been made in the field of ultrasoundimaging with the creation of multiple aperture imaging, some examples ofwhich are shown and described in U.S. Pat. No. 8,007,439 titled “Methodand Apparatus to Produce Ultrasonic images Using Multiple Apertures,”U.S. patent application Ser. No. 13/029,907, filed Feb. 18, 2010, nowU.S. Pat. No. 9,146,313, titled “Point Source Transmission andSpeed-Of-Sound Correction Using Multiple-Aperture Ultrasound Imaging,U.S. patent application Ser. No. 12/760,375, filed Apr. 4, 2010, titled“Universal Multiple Aperture Medical Ultrasound Probe,” and U.S. patentapplication Ser. No. 12/760,327, now U.S. Pat. No. 8,473,239, titled“Multiple Aperture Ultrasound Array Alignment Fixture,” all of which areincorporated herein by reference. Multiple aperture imaging methods andsystems allow for ultrasound signals to be both transmitted and receivedfrom separate apertures.

Ultrasound probes constructed to perform multiple aperture ultrasoundimaging typically contain multiple separate transducer arrays. Duringconstruction of such a probe, the multiple arrays need to be aligned ina common imaging plane and in a desired orientation relative to oneanother. Some methods of performing such alignment and construction areshown and described in U.S. patent application Ser. No. 12/760,327, nowU.S. Pat. No. 8,473,239. Room for further improvement remains.

SUMMARY

In one embodiment, a method of building a multiple aperture ultrasoundprobe is provided, the method comprising the steps of forming a gasketwith a first flowable solidifying material on a lower surface of aprecision alignment element, securing the precision alignment element toa back surface of a transducer array with the gasket, evaluating andadjusting alignment of the transducer array relative to the precisionalignment element, and injecting a second flowable solidifying materialthrough at least one hole in the precision alignment element to securethe transducer array to the precision alignment element.

In some embodiments, the injecting step comprises filling a volumedefined by the back surface of the transducer array, the lower surfaceof the precision alignment element, and an inner surface of the gasketwith the second flowable solidifying material.

In some embodiments, the method further comprises allowing the secondflowable solidifying material to solidify, and mounting the precisionalignment element to a probe alignment bracket.

In alternative embodiments, the method further comprises placing theprobe alignment bracket into a probe housing, and injecting a thirdflowable solidifying material into a space between the transducer arrayand the probe housing.

In other embodiments, the injected third flowable solidifying materialsurrounds at least a portion of the precision alignment element or theprobe alignment bracket.

In one embodiment, evaluating alignment of the transducer array relativeto the precision alignment element comprises imaging a target with thetransducer array and comparing a resulting image of the target withknown information defining a geometry of the target.

In some embodiments, the target comprises a plurality of pins orientedin a known configuration relative to the precision alignment element.

In other embodiments, each of the pins has a flat surface substantiallyperpendicular to a longitudinal axis of the pins, the longitudinal axisbeing substantially perpendicular to an ultrasound wavefront transmittedfrom a single element of the transducer array and arriving at the pins.

In some embodiments, adjusting alignment of the transducer arrayrelative to the precision alignment element comprises adjusting at leastone set screw to mechanically move the transducer array relative to theprecision alignment element.

In some embodiments, the method further comprises allowing the firstflowable solidifying material to solidify prior to evaluating andadjusting alignment of the transducer array relative to the precisionalignment element.

In additional embodiments, the first flowable solidifying material andthe second flowable solidifying material are the same material.

In one embodiment, the pins are oriented with longitudinal axes thatintersect at a single point.

A method of evaluating an alignment of an ultrasound transducer arrayrelative to a precision alignment element is also provided, the methodcomprising the steps of flexibly securing the ultrasound transducerarray to the precision alignment element, mounting the precisionalignment element in a fixed, known position and orientation relative toa target, the target having a plurality of reflectors in known reflectorpositions, imaging the reflectors of the target with the array,comparing imaged reflector positions with known reflector positions, andidentifying a corrective adjustment based on the comparing step.

In some embodiments, the method further comprises comparing a brightnessof the reflectors with expected brightness values.

In other embodiments, the method further comprises visually comparingimaged reflector positions with known reflector positions using agraphical user interface in which a first image comprising the imagedreflector positions is displayed simultaneously with a second imagecomprising the known reflector positions.

In alternative embodiments, the graphical user interface furthercomprises a graphical representation of a brightness of imagedreflectors within a predetermined radius of the known reflectorpositions.

An ultrasound probe alignment system is provided, comprising a tankassembly comprising an ultrasound conducting material, an array affixingand adjusting assembly at least partially within the tank assembly, thearray affixing and adjusting assembly supporting a precision alignmentelement in a known position and orientation relative to a targetassembly, the target assembly being disposed in the tank assembly andcomprising at least one reflector configured to reflect an ultrasoundsignal.

Some embodiments further comprise a height adjustment assemblyconfigured to adjust a distance between the array affixing and adjustingassembly and the target assembly.

In other embodiments, the target assembly comprises a plurality of pinsarranged so as to be coincident with a precisely aligned imaging planeof the ultrasound probe alignment system.

In some embodiments, the pins are arranged so as to be displaced fromone another in two dimensions in the imaging plane of the ultrasoundprobe alignment system.

In one embodiment, the pins vary in length so as to lie on multipledifferent points of the imaging plane of the ultrasound probe alignmentsystem.

In alternative embodiments, the plurality of pins comprises a center pinand at least one pair of pins equidistant from the center pin.

In other embodiments, the array affixing and adjusting assemblycomprises structures for adjusting an orientation of an ultrasoundtransducer array relative to the precision alignment element.

A multiple aperture ultrasound probe is provided, comprising a probehousing, a first transducer array secured to a first precision alignmentelement by a layer of a solidified polymer material, the first precisionalignment element comprising a first plate secured to a back surface ofthe first transducer array, the first precision alignment element beingsecured to a probe bracket of the probe housing, a second transducerarray secured to a second precision alignment element by a layer of asolidified polymer material, the second precision alignment elementcomprising a second plate secured to a back surface of the secondtransducer array, the second precision alignment element being securedto the probe bracket of the probe housing, and a filler solidifiedpolymer material disposed in a space between the first and secondtransducer arrays and the probe housing.

In some embodiments, the first and second arrays are precisely alignedrelative to the first and second precision alignment elements,respectively.

In other embodiments, the first precision alignment element comprises aplate having at least one hole through which a quantity of solidifiedpolymer material extends.

In one embodiment, the plate comprises two holes, at least one of whichhas a quantity of solidified polymer material extending therethrough.

In some embodiments, the first precision alignment element is secured toa single surface of the first transducer array.

In additional embodiments, the first precision alignment element issecured to the probe bracket by a plurality of mechanical fasteners.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is a perspective view of an embodiment of a fully assembledmultiple aperture ultrasound imaging probe.

FIG. 2 is a flow chart illustrating an embodiment of a high-levelprocess for aligning transducer arrays during assembly of a multipleaperture ultrasound probe.

FIG. 3 is a perspective view of an embodiment of a fixture assembly anda target for aligning a transducer array.

FIG. 4 is an exploded view of an embodiment of the adjustment assemblysection of the fixture assembly of FIG. 3.

FIG. 5 is a perspective view of an embodiment of an alignment targetmade up of a plurality of pins.

FIG. 6 is an exploded view of an embodiment of a transducer array, agasket element, and a precision alignment element.

FIG. 7 is a perspective view of an embodiment of the lower side of theprecision alignment element of FIG. 6.

FIG. 8 is a perspective view of an embodiment of jig for establishingthe thickness of the gasket of FIG. 6.

FIG. 9 is a perspective view of an embodiment of a transducer arraymounted in an adjustment assembly.

FIG. 10 is a block diagram illustrating an embodiment of an imagingcontroller for use with some embodiments of the alignment systems andmethods herein.

FIG. 11A is an illustration of an embodiment of an array alignmentdisplay screen showing an image of an array that is out of alignment.

FIG. 11B is an illustration of an embodiment of an array alignmentdisplay screen showing an image of an array that is well-aligned.

FIG. 12 is a perspective view of an embodiment of a probe alignmentbracket for use in supporting transducer arrays in a designedorientation relative to a probe housing and relative to one another.

FIG. 13 is a cross-sectional view of an embodiment of a completedmultiple aperture ultrasound probe assembled using the systems andmethods described herein.

DETAILED DESCRIPTION

The following disclosure provides embodiments of systems and methods forconstructing accurately aligned multiple aperture ultrasound probes.Some embodiments provide systems and methods for checking, adjusting,and securing the alignment of an individual array relative to aprecision alignment element (PAE). Some embodiments provide systems andmethods for mechanically aligning and affixing multiple transducerarrays in a desired alignment relative to one another and relative to aprobe housing.

It is important that ultrasound probes to be used in high resolutionmultiple aperture ultrasound imaging be precisely constructed such thateach of a plurality of transducer arrays be precisely aligned along acommon imaging plane. It is further important that such arrays bemounted within a probe housing at a precise angle, orientation andposition relative to each other and relative to the probe housingitself.

As used herein, references to the “exact” or “precise” position oftransducer elements (and similar terms) may imply a relatively tighttolerance. For example, in some embodiments ultrasound probe calibrationsystems and methods may provide information describing the acousticposition of each transducer element in an array to within a distance ofa fraction of a wavelength of ultrasound being used. In someembodiments, the acoustic position of transducer elements may bedetermined to within 1/10 of a wavelength. In other embodiments, theacoustic position of transducer elements may be determined to within atolerance of less than 1/10 of a wavelength. In some embodiments, suchas for calibrating a standard (i.e., single aperture) ultrasound probe,much looser tolerances may also be used, provided that such tolerancesmeet the needs of a particular system.

Conventional ultrasound (or “scanline based” ultrasound as used herein)utilizes a phased array controller to produce and steer a substantiallylinear transmit waveform groups. In order to produce a B-mode image, asequence of such linear waveform groups (or “scanlines”) may be producedand steered so as to scan across a region of interest. Echoes arereceived along each respective scanline in a process known as receivebeamforming. The echoes received along the individual scanlines may thenbe combined to form a complete image.

In a ping-based imaging process, an unfocused circular wavefront istransmitted from a point source transmitter, and the echoes are receivedby a plurality of receive transducers. The received echoes may then bebeamformed using a ping-based beamforming process in order to determinea display location for each reflector that returns an echo. Beamformingis generally understood to be a process by which imaging signalsreceived at multiple discrete receptors are combined to form a completecoherent image. The process of ping-based beamforming is consistent withthis understanding.

Embodiments of ping-based beamforming generally involve determining theposition of reflectors corresponding to portions of received echo databased on the path along which an ultrasound signal may have traveled, anassumed-constant speed of sound and the elapsed time between a transmitping and the time at which an echo is received. In other words,ping-based imaging involves a calculation of distance based on anassumed speed and a measured time. Once such a distance has beencalculated, it is possible to triangulate the possible positions of anygiven reflector. This distance calculation is made possible withaccurate information about the relative positions of transmit andreceive transducer elements. Further details of ping-based imaging aredescribed in U.S. patent application Ser. No. 13/029,907, now U.S. Pat.No. 9,146,313, referenced above.

Embodiments of Alignment Array Fixtures and Assemblies

FIG. 1 illustrates an assembled multiple aperture ultrasound probe 10.The probe 10 of FIG. 1 includes three separate transducer arrays 12A,12B, 12C, each of which may be secured (or “potted”) in a precisedesired position and orientation within a probe housing 14. In someembodiments, the arrays may be potted in the probe housing 14 with aflowable solidifying material such as a room temperature vulcanizing(RTV) silicone rubber or any other similarly suitable epoxy orpolymerizing material. RTV silicone is particularly suitable due to itsthermal and mechanical properties, but other materials with similarproperties may also be used. Generally any reference herein to a“flowable solidifying material,” a “solidifying polymer material,” a“flowable hardening material” or an “acoustic damping material” mayrefer to any suitable material that transitions from a liquid to a solidby a curing, drying or polymerizing process. Such materials may includeRTV silicone, two-part epoxy resins, or others.

In general, it may be desirable for a flowable solidifying material tohave properties in its solid state that are similar to properties of amedium to be imaged and similar to a lens material attached to amanufactured transducer array (which may also be specified forparticular applications). RTV silicone is well-suited to medicalapplications while more rigid materials, such as hard-curing epoxies ora metal-impregnated epoxies may be well-suited to non-destructivetesting applications. In still further embodiments, a flowablesolidifying material may be a phase-changing material. For example, amolten plastic may be flowed as needed, and then allowed to solidify bycooling to a temperature below a melting point.

In various alternative embodiments, multiple aperture probes may beconstructed with 2, 3, 4, 5, 6, 7, 8, 9, 10 or more individualtransducer arrays in a common housing. In some embodiments, alltransducer arrays in a probe may be oriented in a common imaging plane.In other embodiments, some arrays may be aligned in multiple imagingplanes so as to facilitate 3D or 4D imaging. Generally, multipleaperture probes are designed with relatively tight tolerances for theposition and orientation of arrays within the probe housing. In order tomeet these tolerances while assembling a probe, an alignment andaffixing process may be needed.

FIG. 2 illustrates an example of a process 20 for aligning one or morearrays relative to a precision alignment element (PAE) and affixing theone or more arrays to the PAE. The process 20 of FIG. 2 may begin withthe step of mounting an array to a PAE 22 in such a way as to allow forthe position and/or orientation of the array to be adjusted relative tothe PAE. The PAE may then be mounted 24 to an alignment/adjustmentassembly. Using the alignment/adjustment assembly, the alignment of thearray relative to the PAE may be tested 26. The result of the test maybe evaluated 28 to determine whether the array is sufficiently alignedwith the PAE. If the testing 26 reveals that the alignment of the arrayrelative to the PAE is outside of a desired tolerance 30, then thearray's alignment may be adjusted 32, and the alignment may be re-tested26. Once the array is determined to be aligned with the PAE to within adesired degree of precision 34, the array may be more permanentlyaffixed to the precision alignment assembly 36. The aligned array & PAEassembly may then be mounted to a probe alignment bracket 38, and whenall such PAE/array assemblies are mounted to the probe bracket, theentire assembly may be placed into a probe housing 40, and the entireassembly may be permanently potted into the probe housing 42. Theembodiments of various structures that may be used for such a processwill now be described before describing further detailed embodiments ofan alignment process 20.

FIG. 3 illustrates one embodiment of an alignment and adjustmentassembly 50. In the illustrated embodiment, the assembly 50 may includea tank-affixing section 52, an array affixing and adjusting assembly 54,and a target assembly 56. The assembly 50 of FIG. 3 may be generallyconfigured such that a PAE 60 may be supported in a known preciselyaligned position and orientation relative to a target to be imaged, suchas pins 66, 66T. The orientation of an array 62 attached to the PAE 60may be tested by imaging the target 56 (or more particularly pins 66,66T in some embodiments) using the array 62 and evaluating the resultingimage (as described in further detail below). If the array 62 is foundto be out of alignment, the orientation of the array 62 relative to thePAE 60 may be adjusted using the adjustment assembly 54 (as described infurther detail below with reference to FIG. 9).

In the illustrated embodiment, the PAE 60 may be secured to the assembly54 by arms 57. In alternative embodiments, any number of otherstructures may also be used depending on the shape and configuration ofthe PAE and other portions of the alignment assembly 50. In otherembodiments, the PAE 60 may also include further structures and featuresdesigned to enable precise alignment of the PAE 60 with components ofthe assembly 54. An Adjustment cover 61 may also be provided to surroundthe array 62, and to provide structure for a plurality of adjustmentscrews 63.

In some such embodiments, the alignment assembly 50 of FIG. 3 may beconfigured to allow the distance between the array 62 and the target 56to be increased or decreased by known amounts. For example, the arrayaffixing and adjusting assembly 54 may be mountable at a plurality ofdiscrete locations 59 relative to the target assembly 56. In alternativeembodiments, a continuously variable height adjustment mechanism, suchas a rack and pinion (or any other suitable mechanism) may be used tovary the height of the probe affixing assembly 54 relative to the target56.

In some embodiments, all or part of the assembly 50 may be mountedrelative to a tank containing a liquid bath such that at least thetarget assembly 56 and the emitting surface of the transducer array 62may be submerged in a liquid medium with a known consistent speed ofsound (e.g., water, gel, oil or other material as described in furtherdetail below). In various embodiments, the tank-affixing section 52 mayinclude any structure for affixing the assembly 50 relative to a watertank such that at least the array transducers 60 and the target 56 aresubmerged.

In other embodiments, the water tank may be omitted. For example, atarget assembly 56 may be encased within a solid material with a knownconsistent speed-of-sound (e.g., RTV silicone, ballistic gelatin, or anyother solid elastic material suitable for use in ultrasound phantoms),and the transducer array 60 to be aligned may be acoustically coupled toa surface of the target assembly by an acoustic coupling gel or aconformable bladder containing a liquid or gel. In such embodiments, thematerial in which the target is encased may be selected based on thefrequency and style of array under test. For example, whereas medicaltransducers are designed in the 1 to 18 MHz area, ideal target-encasingmaterials may have similar characteristics to human tissue. On the otherhand, a transducer to be used in non-destructive testing (NDT) ofindustrial materials may be designed to operate at substantially higherfrequencies in order to evaluate metals and composites. Some NDT arraysmay also be air-coupled, doing its job without ever touching the worksurface. Such devices typically work at much lower frequencies. Acoupling medium is a bridge to allow energy of an appropriate frequencyto travel back and forth from the testing array to the object under test(e.g., a phantom containing an alignment target). In the case of medicalarrays and some low frequency NDT arrays, a coupling medium may includecompatible gels, lotions, oils or water depending on the materials to beimaged. Higher frequency NDT arrays might use water, oil or acombination of liquids as a coupling medium. In some embodiments, acoupling medium may comprise a flexible bladder or pad of a materialwith suitable properties.

FIG. 4 provides an exploded view further illustrating components of thearray affixing and adjusting assembly 54 of FIG. 3. The array-holdingassembly 54 may be secured in a consistent and known position andorientation relative to the target assembly 56. Thus, depending on theshape and nature of the target assembly, various structures may be usedto maintain the array-holder 54 in a known position relative to thetarget assembly. In the embodiment of FIGS. 3 and 4, the target assembly56 may be secured to the array holder assembly 54 with rigid arms 58.Any other alternative structures may also be used.

FIG. 5 illustrates an embodiment of a target assembly 56 that may beused in an alignment process. In various embodiments, the targetassembly 56 may include any structure with a known configuration ofacoustic reflectors. A target 56 for use with an alignment process maygenerally have a pattern of reflectors that will allow for a clearindication of the array's alignment relative to the target 56. Targetsideal for an alignment process are those that include a plurality ofreflectors (or holes) that lie in a precise known pattern in a singleplane that may be precisely aligned with the intended imaging plane ofthe array. For example, the target assembly 56 shown in FIGS. 3-5comprises a plurality of pins 66 (labeled as pins 66A-D and T in FIG. 5)arranged such that all of the pins 66 lie in a common plane that iscoincident with the precisely aligned imaging plane.

As best seen in FIG. 5, the pins 66A-D and T may vary in length suchthat the tips of the pins may lie on multiple different points in theintended image plane (i.e., at different heights relative to a planeperpendicular to the imaging plane). In some embodiments, the pins maybe oriented at angles such each pin's flat surface end may be orientedperpendicular to an arriving waveform transmitted from the array. Insome embodiments, such angles may be selected assuming pings aretransmitted from an origin at the center point of the array, even ifpings are to be transmitted from multiple transmit elements at differentlocations on the array.

In some embodiments, target pins may be arranged in a common imagingplane and oriented at angles such that longitudinal axes of the pinsintersect at a single point near the transducer array (e.g., above thetransducer array's transmitting surface in some embodiments). Forexample, in some embodiments, pins furthest from a center pin (the endpins) may be oriented such that, with the target positioned at a minimumdistance from the array, the end pins lie at a desired angle relative tothe precision alignment element. For example, the end pins may beoriented at an angle of about 30 degrees relative to a lineperpendicular to the precision alignment element in the imaging plane.Larger or smaller angles may be desirable depending on an angle ofsensitivity of transducer elements in transducer arrays to be aligned.

When imaged by a transducer array to be aligned, each pin may appear asa dot. In this target configuration, each pin may appear as a dot in aknown location on a display when the target is imaged by an alignedarray supported in the array holder assembly.

In some embodiments, a target 56 may include a plurality of reflectorspositioned so as to evaluate the array's alignment at various discretedistances from the target. For example, a target may include a centerpin 66T and a plurality of pairs 66A-66D of pins laterally spaced equaldistances from the center pin 66T. In various embodiments, a target mayinclude any number of pairs of laterally-spaced pins. In someembodiments, the pairs of pins may be provided in a range of differentlengths, meaning that some pairs of pins are closer to the transducerarray than others. In various embodiments, alignment of an array may beevaluated at various distances from the target. In some embodiments, pinlengths may be calculated so as to place the faces of each pair of pinsand the center pin 66T coincident with an arc of a transmitted wavefrontat a selected depth.

In some embodiments, different reflectors of the target 56 may beconfigured and used for evaluating the array's alignment at differentdistances from the target 56 and/or for evaluating the arraytransmitting at different frequencies. For example, the target shown inFIG. 5 may include several pairs of reflectors of different lengths tobe imaged at different vertical distances between the array and thetarget. As shown, the first pair of reflectors 66A may be configured forevaluating an array's alignment at a target-distance of about 1.5 cm,the second pair 66B of reflectors may be configured for evaluating anarray's alignment at a target-distance of about 3.0 cm, the third pair66C may be configured for evaluating an array's alignment at atarget-distance of about 4.5 cm, and the fifth pair 66D may beconfigured for evaluating an array's alignment at a target-distance ofabout 6.0 cm. In alternative embodiments, targets may be configured fortesting an array at any distance as desired.

In further alternative embodiments, the target 56 may include phantomstructures with reflectors made of any suitableultrasonically-reflecting material in a variety of alternativeconfigurations. For example, the target may comprise a plurality ofsmall sphere-shaped reflectors embedded in a solid material. Generally,a target may include any number of reflectors made of an appropriateechogenic material, as determined by the frequency and array style, thatprovides a small reflective surface relative to the wave length of thesound being used. Such reflective objects may be encased in preciselyknown locations in a sonolucent material. The sonolucent material to beused may be selected to be similar to conditions to be experienced bythe array in an intended application. As such, in some cases, asonolucent material may or may not offer attenuation. Reflectors in atarget assembly need not be arranged in a symmetrical pattern, butpreferably include multiple points at multiple different known locationssuch that alignment may be evaluated. The target may generally includeany pattern of reflectors which may be supported within a solid, liquidor gaseous medium (depending on the intended use application). In someembodiments, a target may also include one or more “holes”—regions orobjects that substantially absorb and do not reflect significantultrasound signals. In some embodiments it may be desirable forreflectors or holes to be aligned in a single plane that is may bealigned with the ideal imaging plane.

In some alternative embodiments, a target may include any substantiallystatic object that may be imaged with an ultrasound probe. For example,any number of phantoms designed for sonographer training are widelycommercially available from various suppliers of medical equipment. Somecommercially available phantoms are made to mimic the imagingcharacteristics of objects to be imaged such as specific or generichuman tissues. Such properties may or may not be used in combinationwith various embodiments described herein. An object need not bepurpose-built as a phantom to be used as a phantom for the alignmentprocesses described herein.

As shown in FIG. 6, in some embodiments, the PAE 60 may include a plate70 with precisely positioned mounting holes 72 precisely arranged forattachment to the holder 54. For example, in some embodiments the PAE 60may include two alignment mounting holes 72 configured to mount the PAE60 to mounting arms 57 of the adjustment assembly (shown in FIGS. 3 and4). The PAE 60 may further include corner holes 74A-74D for receivingset screws and for mounting the PAE 60 to a probe alignment bracket in afinal probe assembly (e.g., as described below with reference to FIG.12). In some embodiments, temporary set screws in the corner holes74A-74D may also be used to adjust the position of an array relative tothe PAE during an alignment procedure as described in further detailbelow. In some embodiments, the corner holes 74A-74D may be tapped withfine pitch threads.

In alternative embodiments, a precision alignment element may beprovided in a variety of different structures, and may include anysuitable features to ensure and/or to verify accurate and precisepositioning of the PAE 60 relative to the target 56. For example, thePAE may include holes, pins, recesses or other structures configured toengage (or to be engaged by) corresponding structures on a holderassembly. In general, a precision alignment element (or PAE) may be anystructure that may be mounted in a known precise position relative to atarget in an alignment test assembly. Similarly, alternative holderassembly structures may include clamps, screws, pins, holes, recessesand various other mechanical structures configured to engagecorresponding portions of a PAE and to hold a PAE in a consistent knownposition and orientation relative to a target.

In some embodiments, precision alignment features may be integrated intoa probe alignment bracket (such as that described below with referenceto FIG. 12. In such embodiments, a probe alignment bracket configured tosupport transducer arrays in a desired orientation relative to oneanother may include array-mounting sections, gasket-supporting sectionsand holes for injecting a flowable solidifying material once an array isaligned. In such some embodiments, a plurality of targets may beprovided such that each array has a corresponding target arrangedperpendicular to the aligned array plane. Alternatively, a target or aPAE holder may be adjustable so as to position the bracket PAE and thetarget(s) in a perpendicular orientation.

FIG. 6 illustrates an embodiment of a PAE 60 and a gasket 76 foradjustably securing the PAE 60 to a transducer array 62. In someembodiments, the PAE 60 may comprise a plate with a lower surface 78sized and configured to be bonded to a back surface 80 of a transducerarray.

As shown in FIG. 7, in some embodiments the lower surface 78 of the PAE60 may include a recessed section 81. The recessed section 81 may bemachined (or otherwise formed) to a precise depth and dimensions forcreating a gasket 76. In some embodiments, a gasket 76 may be formed byextruding a bead or injecting a flow of a liquid or flowable solidifyingmaterial (e.g., RTV silicone, epoxy or other flowable solidifyingmaterial) around the perimeter of the recessed section 81 on the lowersurface 78 of the PAE 60. In some embodiments, before the solidifyingmaterial cures, the PAE 60 and the gasket 76 may be pressed onto theback surface 81 of the transducer array 62.

In some embodiments, a jig 82, such as that shown in FIG. 8, may be usedto ensure that the gasket 76 is compressed to a consistent thickness.Using the jig 82, a consistent desired gasket thickness may be achievedby placing the PAE 62 in the provided slot 84, and then placing thetransducer array 62 into the space above the PAE 62 until it abuts theshoulders 86 such that the height of the shoulders 86 above the PAE'slower surface 78 ensures a consistent spacing between the lower surface78 of the PAE 60 and the back surface 80 of the transducer array 62.

It is generally desirable for the gasket to secure the PAE to the arraywhile remaining somewhat flexible, allowing a small degree of movementbetween the PAE and the array during the alignment and adjustmentprocess. Such flexibility may be achieved through selection of anappropriate flowable solidifying material and/or selecting a gasketthickness and width that allows sufficient flexibility. Alternatively,flexibility of the gasket may be achieved by performing the adjustmentprocess before a hardening material completely cures.

In some embodiments, the PAE 60 and array 62 may be held within the jig82 for a sufficient time for the gasket material to cure. Once cured,the PAE 62 will be temporarily secured to the back surface 80 of thetransducer array 62 by the gasket, while allowing a small range ofmovement between the PAE 60 and the array 62. Although the use of a jigmay provide a certain degree of precision to the assembly, the actualacoustic position of the transducer elements may not necessarily beprecisely consistent with the physical back surface 80 of the transducerarray 62 simply due to inevitable manufacturing variability.

In some embodiments, the PAE 60 may also include features and structuresconfigured to facilitate precise alignment of the PAE 60 and an attachedtransducer array 62 with elements of a final probe assembly. Forexample, as shown in FIG. 6, the plate 70 may also include a pluralityof holes 74A-74D precisely positioned for precisely mounting thealignment element 60 to a probe alignment bracket as will be describedin further detail below with reference to FIG. 12. In some embodiments,the plate 70 may also include one or more channels 92 precisely sizedoriented to engage corresponding structures in a probe alignmentbracket.

In some embodiments, the PAE 60 may include one or more injection holes94 through which a flowable solidifying material may be injected oncethe transducer array is determined to be perfectly aligned with the PAE(as will be described in further detail below with reference to FIG. 9).The PAE 60 may also include a relief 96 surrounding the injection holes94 to prevent any overflowing affixing material from interfering withthe fit of the PAE in a probe alignment bracket (as described in furtherdetail below).

FIG. 9 illustrates an array 62 to be aligned to a precision alignmentelement 60 and mounted in an adjustment assembly 54. The adjustmentassembly 54 may generally include one or more adjustment mechanismsconfigured to move the array 62 relative to the PAE 60. In theillustrated embodiment, a plurality of set screws 63A-63C may beprovided as adjustment mechanisms. A spring 98 (or other resilientmaterial or device) may also be provided to mechanically bias the arraytowards the adjustment mechanisms so as to maintain contact between thearray 62 and the set screws 63A-63C. In some embodiments, apoint-contact device may be positioned between the spring 98 and thearray 62. A point-contact device may be any structure that creates asmall point of contact with the array, such as a pin, a nail, a sphere,a cone, or otherwise shaped structures. Any number of set screws in anydesired arrangement may be used to adjust the position of the array 62relative to the PAE 60.

FIG. 9 illustrates several set screws 63A-63C for adjusting the positionof the array 62 relative to the PAE. The six adjustment set screws inthe front surface of the adjustment cover 61 may be used for adjustingthe position of the array by displacing a portion of the array in the Ydirection. For example, tightening the bottom of the center screws 63Bwill tend to cause the array to pivot about the longitudinal axis 102,while tightening the right-side screws 63C or the left-side screws 63Awill tend to cause the array 62 to pivot about the vertical axis 106.Tightening all of the front screws (or at least the top left and rightside screws) may cause the array 62 to translate along the elevationaxis 104. In some embodiments, adjustment set screws may also be used inone or more of the four corner holes 74A-74C in the PAE 60. Tightening aset screw in the screw right rear hole 74B will tend to cause the arrayto pivot about the longitudinal axis and the elevation axis. Thus,depending on the degree and the direction of misalignment detectedduring a testing step, one or more set screws may be adjusted until adesired adjustment of the array's position relative to the PAE 60 isachieved.

In various embodiments, ribbon connectors extending from the array maybe electrically connected to a controller in order to transmit and/orreceive ultrasonic signals using the transducer array. Any suitableconnector may be used for achieving such electrical connections.

Alignment Imaging Controller Embodiments

FIG. 10 illustrates a block diagram of a controller 200 that may be usedfor controlling, transmitting, and receiving of ultrasound signals usingthe transducer array 62 during an alignment process. The controller 200may also be configured to generate and display images based on thereceived echo data. In some embodiments, the controller 200 may furtherbe configured to store raw echo data for later retrieval and analysis.

As shown in FIG. 10, a controller 200 may electronically and logicallyconnected to a transducer array 202 to be aligned. In some embodiments,at least some of the transducer elements may be designated as transmitelements, while others may be designated as receive elements. In someembodiments, each transducer element may convert ultrasound vibrationsinto time-varying electrical signals and vice versa. In variousembodiments, the array 62 to be aligned to a PAE may include any numberof ultrasound transducer elements in any desired configuration.

The controller 200 may contain software and hardware elements configuredto control an imaging process. In various embodiments of the alignmentmethods described herein, any imaging method (e.g., ping-based imaging,scanline-based imaging or any other available ultrasound imaging method)may be used for imaging the target assembly. Due to the use oftransducer element position in ping-based beamforming methods, suchmethods may be particularly suited for an alignment evaluation process.

The transmission of ultrasound signals from elements of the array 62 maybe controlled by a transmit controller 204. Upon receiving echoes oftransmit signals, the transducer elements may generate time-varyingelectric signals corresponding to the received ultrasound vibrations.Signals representing the received echoes may be output from the array 62and sent to a receive subsystem 210. In some embodiments, the receivesubsystem may include multiple channels (e.g., one channel for eachtransducer element in some embodiments). Each channel may include ananalog front-end device (“AFE”) 212 and an analog-to-digital conversiondevice (“ADC”) 214. In some embodiments, each channel of the receivesubsystem 210 may also include digital filters and data conditioners(not shown) after the ADC 214. In some embodiments, analog filters priorto the ADC 214 may also be provided. In some embodiments, the output ofeach ADC 214 may be directed into a raw data memory device 220. Notably,the controller 200 need not include a scan converter for systemsconfigured to use a ping-based imaging method.

In some embodiments, raw echo data may be stored in a raw data memorydevice 220 prior to any beamforming or image formation. In someembodiments, echo data may be passed directly from a receive subsystem210 to an image formation sub-system 230.

The image formation sub-system 230 may include a beamformer 232 and animage layer combiner (“ILC”) 234. If needed, image data may betemporarily stored in an image buffer memory device 236. In someembodiments, the image formation subsystem may retrieve stored echo datafrom the raw data memory device rather than receiving real-time echodata from the receive sub-system. The beamformer 232 may include or mayhave logical access to a memory device 238 containing transducer elementposition data. In the case of a new un-aligned and un-calibratedtransducer array, such transducer element position data may be based onan idealized case for transducer arrays of a particular type.Alternatively, the transducer element position data may be based oncalibration analysis of a plurality of previously-aligned arrays.

An alignment overlay subsystem 235 may include stored data includinginformation describing known positions of reflectors in the target 56.In some embodiments, such an alignment overlay sub-system may includeinformation for several targets which may be selectable by a userdepending on which target is to be used. The alignment overlay subsystemmay also include hardware and software for forming an image of expectedreflector positions and additional information for assisting inassessing the alignment of a transducer array under examination.

The controller 200 may be further configured to output image data to adisplay sub-system 240. A display subsystem 240 may include a videoprocessor 242 for performing various digital video image processingsteps, a video memory 246 for storing “cine loop” data (e.g., processedvideo clips), and a display controller 244 configured to output imagepixels to a display device.

Array Alignment Testing and Adjustment Method Embodiments

Thus, returning to the process diagram of FIG. 2, an embodiment of aprocess for aligning a transducer array 62 relative to a PAE 60 using analignment apparatus such as that shown in FIGS. 3-6 will now bedescribed. Once a PAE 60 has been temporarily mounted to an array 62with a gasket 76, the PAE 60 and array 62 may be mounted in theadjustment section 54 of an alignment assembly 50. Ribbon connectorsextending from the array 62 may then be electronically connected to analignment imaging controller 200. In some embodiments, the degree ofalignment (or misalignment) may then be tested by imaging the targetassembly 56 with the array 62.

Because the position of the pin tips 66 may be known with a high degreeof precision, the expected image produced by a perfectly-aligned arraymay be predicted with a high degree of precision. Thus, the actualobtained image may be compared with the theoretically ideal image, andthe alignment of the array may be quantitatively and/or qualitativelyevaluated. In some embodiments, such a qualitative comparison may beperformed visually by a user. In order to assist in visually comparingthe actual image with the theoretical image, a software layer may beconfigured to overlay a schematic representation of the theoreticalimage with the actual image. In some embodiments, the two images may bedisplayed in contrasting colors to further aid in distinguishing theactual image from the theoretical image.

FIGS. 11A and 11B illustrate an embodiment of an actual image of atarget with five reflectors in precisely known positions. The reflectorimages are indicated by the amorphous-shaped patterns 110A-110E, and anoverlaid theoretical image is indicated by the circles 112A-112E. FIG.11A illustrates an example of an actual image that is misaligned withthe target (and therefore, the array 62 is misaligned with the PAE 60,since the PAE 60 is known to be precisely aligned with the target). Insome embodiments, a bar graph 114 (and/or a numerical value, a linegraph or other quantitative visual information) may be displayed alongwith the theoretically correct image. Each bar of the bar graph 114 mayindicate the intensity of reflectors lying within the ideal targetregion defined by one of the circles 112. Thus, each bar 115A-115E maycorrespond to each circle 110A-110E, which correspond to known positionsof the reflectors (e.g., pins 66). A higher bar level may indicatebetter alignment of the actual image with the theoretical image for agiven reflector position 110.

In the example of FIG. 11A, the center pin image 110C appears to bewell-aligned while the images of the pins on the left 110A, 110B appeartoo high, and the image of the pins on the right 110D, 110E appear toolow. This pattern may indicate that the array is misaligned in rotationabout the elevation axis 104 (i.e., the left side of the array is tooclose to the target, and the right side of the array is too far awayfrom the target), In view of this misalignment, the array 62 may beadjusted by tightening the right-side set screws 74B, 74C.

Misalignment due to rotation about the longitudinal axis 102 may bedetected by recognizing that the images of all of the pins 110A-110C (orat least the center pin image 110C) is not as bright as expected. Suchmisalignment may be corrected by adjusting either the front screws 74D,74C in the PAE or the rear PAE screws 74A, 74B depending on thesuspected direction of misalignment about the longitudinal axis. In somecases, similar adjustments may be made my adjusting screws 63A-63C inthe adjustment cover 61.

Misalignment about the vertical axis 106 may result in the images ofpins further from the center being progressively less bright than thecenter pin image 110C. Such misalignment about the vertical axis may becorrected by tightening one or more of the adjustment screws 63A or 63Cin the front plate 61 of the adjustment assembly 54.

In some embodiments, an assessment of the alignment of an array undertest may be made based primarily on the imaged position of the centerpin 110C and a single pair of pins equidistant from the center pin 110C.For example, the degree and direction of any misalignment of the arraymay be determined by evaluating the imaged position of only the centerpin 110C and the two next-closest pins 110B and 110D relative to theexpected positions of those pins.

FIG. 11B illustrates an example of an image that may be produced by anarray that is substantially perfectly aligned with the target 56 and thePAE 60. In some embodiments, the degree of variation from the idealimage that may be allowable within a designed tolerance may bedetermined by experimentation.

In some embodiments, the step 26 (in the process of FIG. 2) of testingthe alignment of an array 62 relative to a PAE 60 may be performed usinga tank assembly such as that shown and described in U.S. patentapplication Ser. No. 12/760,327, now U.S. Pat. No. 8,473,239. In thatsystem, the alignment of an array supported at an upper part of a tankmay be tested by transmitting an ultrasound signal from the array andreceiving echoes using a separate set of hydrophones located at thebottom of the tank.

With reference to FIGS. 6 and 9, once the array is found to besufficiently aligned, the array 62 may be fixed in the new positionrelative to the PAE 60 by injecting a low viscosity flowable solidifyingmaterial through the injection holes 94 in the PAE. The solidifyingmaterial used in this step may have a sufficiently low viscosity toallow easy injection and filling of the space between the PAE and thearray without altering the array's alignment relative to the PAE. Thesolidifying material may then be allowed to cure. In some embodiments, aquantity of flowable solidifying material may be injected into one hole94 until the liquid solidifying material is seen extruding from thesecond hole 94. In other embodiments, a measured quantity of theflowable solidifying material approximately equal to the volume of thespace between the PAE 60 and the back surface 80 of the array 62. Excesssolidifying material may be allowed to extrude from the second hole.Once the solidifying material has cured, the array 62 will be secured tothe PAE 60 in the aligned orientation, thus forming an aligned array-PAEassembly. At this point, the set screws may be removed or backed outfrom the adjusted positions, and the aligned array-PAE assembly may beremoved from the adjustment and alignment assembly 54. If needed, theprocess may be restarted for a new array.

In various embodiments, some or all of the process of testing andadjusting alignment of a transducer array may be automated. For example,software may be provided and configured for evaluating misalignment ofan array and selecting a suitable corrective adjustment as describedabove. Furthermore, robotic elements may be provided and configured toadjust the various set screws in order to automatically apply acorrective adjustment selected by a software agent. A robotic elementmay also be provided for injecting a quantity of a flowable solidifyingmaterial into the space between the PAE and the array.

Probe Assembly Method Embodiments

Once a sufficient number of arrays have been aligned to their respectivePAEs, the aligned arrays may be mounted to a probe alignment bracket 120such as that shown in FIG. 12 before final assembly into a probe housing14 (FIG. 13). In some embodiments, a probe alignment bracket 120 may beprovided with a plurality of array-receiving sections 122A-122C. Eacharray-receiving section 122A-122C may include structural features forreceiving a PAE 60 attached to an aligned array 62. In some embodiments,the receiving sections 122A-122C may include ribs configured to engagechannels 92 in the PAE 60 (FIG. 6). The receiving sections 122A-122C mayalso include a plurality of screw holes 124 through which mountingscrews may pass for attaching PAEs 60 to the probe alignment bracket120. The alignment bracket 120 may also include flanges 126 and/or otherfeatures to assist in positioning the PAEs in the proper positions. Inother embodiments, a probe alignment bracket may have a wide range ofshapes and configurations beyond that illustrated here depending on thenumber and designed orientation of arrays to be included in a probe.

In some embodiments, the probe alignment bracket 120 may also includeattachment flanges 128 for securing an electronic connection board (notshown). An electronic connection board may be configured with aplurality of connectors configured for electrical connection to the flexconnectors extending from each transducer array. In some embodiments,the connector board may further include traces connecting the transducerarray connections to a common connector that may be configured forconnection to a cable. Details of some embodiments of such connectorboards and cabling assemblies may be seen in Applicants' U.S. patentapplication Ser. No. 13/272,098 titled “Multiple Aperture Probe InternalApparatus and Cable Assemblies,” which is incorporated herein byreference.

The probe internal assembly including the probe alignment bracket 120,connector board and aligned array-PAE assemblies may then be insertedinto a probe housing 14 as shown in FIG. 13. In various embodiments, aprobe housing 14 may include a one-piece construction, a clamshellconstruction, or any other suitable configuration. In some embodiments,portions of the internal assembly may be attached to portions of theprobe housing by screws, bolts, clamps, clips, pins, or any othersuitable attachment device.

Once the internal assembly is fully inserted into a probe housing 14,the aligned arrays 12A-12C and the probe alignment bracket 120 to whichthey are mounted may be permanently potted by injecting a flowablesolidifying material 130 such as RTV silicone into the shell housing,surrounding at least portions of the arrays 12A-12C. In someembodiments, a flowable solidifying material 130 may also be injectedfurther into the probe housing 14 so as to surround all or portions ofthe probe alignment bracket 12. In some embodiments, the flowablesolidifying material may be used to substantially fill the space betweenthe arrays and the sides of the probe housing 14. The solidifyingmaterial may also be smoothed out so as to provide a substantiallyconsistent surface with the front surfaces of the arrays 12A-12C.

Embodiments of Completed Probe Assemblies

In various embodiments, a final probe assembled using the systems andmethods described above may have some unique characteristics, some ofwhich are illustrated in FIG. 13. As shown in the cross-sectional viewof FIG. 13, a completed probe may include a plurality of transducerarrays 12A-12C potted into the probe housing 14 by a quantity of asolidified potting material 130 (e.g., RTV silicone or any othersolidified flowable solidifying material). Each transducer array 12A-12Cmay be seen to be secured to a precision alignment element 60A-60C by anadditional layer of a solidified material 132 between the precisionalignment element 60 and the transducer array 12 (62). The layer ofsolidified material 132 may include the gasket (76 in FIGS. 6 and 7) andthe affixing layer of solidifying material injected after aligning thearray to the PAE. The precision alignment elements 60A-60C are, in turn,mounted to a probe alignment bracket 120 in precise positions.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. Various modifications to the above embodiments will be readilyapparent to those skilled in the art, and the generic principles definedherein may be applied to other embodiments without departing from thespirit or scope of the invention. Thus, it is intended that the scope ofthe present invention herein disclosed should not be limited by theparticular disclosed embodiments described above, but should bedetermined only by a fair reading of the claims that follow.

In particular, materials and manufacturing techniques may be employed aswithin the level of those with skill in the relevant art. Furthermore,reference to a singular item, includes the possibility that there areplural of the same items present. More specifically, as used herein andin the appended claims, the singular forms “a,” “and,” “said,” and “the”include plural referents unless the context clearly dictates otherwise.As used herein, unless explicitly stated otherwise, the term “or” isinclusive of all presented alternatives, and means essentially the sameas the commonly used phrase “and/or.” It is further noted that theclaims may be drafted to exclude any optional element. As such, thisstatement is intended to serve as antecedent basis for use of suchexclusive terminology as “solely,” “only” and the like in connectionwith the recitation of claim elements, or use of a “negative”limitation. Unless defined otherwise herein, all technical andscientific terms used herein have the same meaning as commonlyunderstood by one of ordinary skill in the art to which this inventionbelongs.

What is claimed is:
 1. A multiple aperture ultrasound probe comprising:a probe housing; a probe bracket positioned within and secured to theprobe housing; a first transducer array secured to a substantiallyplanar plate-shaped first precision alignment element by a layer of asolidified polymer material interposed between a bottom surface of thefirst precision alignment element and a back surface of the transducerarray, a top surface of the first precision alignment element beingsecured to the probe bracket; a second transducer array secured to asubstantially planar plate-shaped second precision alignment element bya layer of a solidified polymer material interposed between a bottomsurface of the first precision alignment element and a back surface ofthe transducer array, the second precision alignment element beingsecured to the probe bracket; and a solidified polymer material disposedin a space between the probe bracket and the probe housing.
 2. The probeof claim 1, wherein the first and second arrays are precisely alignedrelative to the first and second precision alignment elements,respectively.
 3. The probe of claim 1, wherein the first precisionalignment element comprises at least one hole through which a quantityof solidified polymer material extends.
 4. The probe of claim 3, whereinthe plate comprises two holes, at least one of which has a quantity ofsolidified polymer material extending therethrough.
 5. The probe ofclaim 1, wherein the back surface of first transducer array isapproximately parallel to a surface defined by transducer elements. 6.The probe of claim 1, wherein only the back surface of the firsttransducer array is secured to only the bottom surface of the precisionalignment element.
 7. The probe of claim 1, wherein the first precisionalignment element is secured to the probe bracket by a plurality ofmechanical fasteners.
 8. The probe of claim 1, wherein the firstprecision alignment element is a rectangular plate comprising aplurality of bracket-mounting holes adjacent corners of the rectangleand at least two alignment mounting holes located away from the corners.9. The probe of claim 1, wherein the probe bracket comprises a ribengaging channels in the top surfaces of the first and second precisionalignment elements.